{"id":8721,"date":"2020-04-14T20:27:20","date_gmt":"2020-04-15T00:27:20","guid":{"rendered":"http:\/\/box5506.temp.domains\/~direxaco\/?page_id=8721"},"modified":"2022-11-22T12:01:37","modified_gmt":"2022-11-22T17:01:37","slug":"events","status":"publish","type":"page","link":"https:\/\/direxaconsulting.com\/?page_id=8721","title":{"rendered":"EVENTS"},"content":{"rendered":"

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Events<\/h1>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.16″ background_color=”#f7e0a5″ global_colors_info=”{}”][et_pb_row column_structure=”3_5,2_5″ custom_padding_last_edited=”on|desktop” _builder_version=”4.16″ background_color=”rgba(0,0,0,0)” custom_margin=”|||auto|false|false” custom_padding_tablet=”” custom_padding_phone=”” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.16″ global_colors_info=”{}”][et_pb_text admin_label=”Recent Events” _builder_version=”4.19.1″ custom_padding=”14px||||false|false” border_width_top=”2px” border_color_top=”#a38b49″ border_width_bottom=”2px” border_color_bottom=”#a38b49″ global_colors_info=”{}”]<\/p>\n

Recent Events<\/h4>\n

[\/et_pb_text][et_pb_text admin_label=”IABS 2022″ _builder_version=”4.19.1″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

8th Annual IABS Statistics Workshop \u2013 November 7 \u2013 10, 2022<\/a><\/h5>\n

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Advancing the Impact of CMC Statistics for a New Generation of Statisticians, Scientists, and Modelers<\/span><\/span><\/a><\/strong><\/p>\n

November 7-10, 2022<\/strong><\/p>\n

A Virtual Meeting<\/strong><\/p>\n

The application of statistics in Chemistry, Manufacturing & Control (CMC) to advance the development and commercialization of important medical products has tremendous impact. New statistical methods and digital and computing technologies are continuously emerging and must often be adapted to add value in the CMC context. Successful practitioners of CMC statistics come from a range of original disciplines, including formal training in statistics, mathematics, and many branches of science and engineering. This conference provides a forum for discussing recent advances and opportunities including Bayesian methods, artificial intelligence & machine learning, and deeper collaboration between clinical & CMC statisticians.<\/p>\n

[\/et_pb_text][et_pb_divider _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_divider][et_pb_image src=”https:\/\/direxaconsulting.com\/wp-content\/uploads\/2021\/05\/Vaccines-Conference.jpg” title_text=”Vaccines Conference” url=”https:\/\/www.pda.org\/global-event-calendar\/event-detail\/2021-pda-vaccines-conference?utm_source=marketo&utm_medium=email&utm_campaign=2021vaccines&utm_content=5.3.21&mkt_tok=MjE3LUFJRC05MzEAAAF80aoTHSls0dCuJSq-4Trj9c39anXcaKxCldX2LiWb8exPO_3hzp94jKBLzaJYZpSZOsxqVOifz2vWDMsXSVDPr1TDDENGV_1rE4UhLyI” admin_label=”Vax Image” _builder_version=”4.16″ _module_preset=”default” box_shadow_style=”preset2″ global_colors_info=”{}”][\/et_pb_image][et_pb_text admin_label=”Vaccines Conference” _builder_version=”4.16″ text_font=”Adamina||||||||” text_text_color=”#000000″ header_2_font_size=”24px” header_3_font=”Adamina||||||||” header_3_text_align=”left” header_3_text_color=”#000000″ header_3_font_size=”20px” header_3_line_height=”2em” header_4_font=”Adamina|700|||||||” header_4_text_color=”#000000″ header_4_font_size=”16px” custom_margin=”||||false|false” border_color_all=”rgba(0,0,0,0)” inline_fonts=”Adamina” global_colors_info=”{}”]<\/p>\n

The 2021 PDA Innovations in Vaccines Conference<\/span><\/span><\/a>, presented virtually 8-9 June, will cover a wide range of important topics related to recent dramatic changes in the vaccines landscape.<\/span><\/strong><\/h4>\n

Here are a few of the highlights of this Conference, with new expert speakers just confirmed!<\/strong> <\/span><\/h4>\n

[\/et_pb_text][et_pb_text admin_label=”Plenary 2: Control Strategies” _builder_version=”4.16″ _module_preset=”default” background_color=”rgba(163,139,73,0.41)” custom_padding=”20px|20px|20px|20px|true|true” global_colors_info=”{}”]<\/p>\n

Plenary 2: Control Strategies<\/span><\/h6>\n

This session will provide insights on advanced control strategies for vaccines development and lifecycle, taking into account product, process, and analytical considerations. Risk-based strategies and technical innovations to enable accelerated development will be discussed.<\/span><\/p>\n

Specific topics include:<\/span><\/p>\n

Quality by Digital Design to Support Rapid RNA Vaccine Production against Emerging Infectious Disease<\/strong> <\/span>
Presented by: Zoltan Kis<\/strong>, PhD, Research Associate, Imperial College London<\/em><\/span><\/p>\n

Enabling Accelerated Development \u2013 Patient-Centric Specifications and Stability <\/span><\/strong>
Presented by: Julia O\u2019Neill<\/strong>, Distinguished Fellow, Moderna, Inc.<\/em><\/span><\/p>\n

[\/et_pb_text][et_pb_text admin_label=”Plenary 4: PDA Vaccine Activities” _builder_version=”4.16″ _module_preset=”default” background_color=”rgba(163,139,73,0.41)” custom_padding=”20px|20px|20px|20px|true|true” global_colors_info=”{}”]<\/p>\n

Plenary 4: PDA Vaccine Activities<\/h6>\n

This session will provide an overview of current activities of the PDA Vaccine Task Force and PDA Vaccine Interest Group, including publications, webinars, meetings on topics of interest for both novel vaccines and more traditional products, and opportunities for volunteering for these initiatives.<\/p>\n

Specific presentations include:<\/p>\n

Vaccines Interest Group Update<\/strong>
Presented by: Jane Halpern<\/strong>, Consultant<\/p>\n

PDA Vaccine Task Force Update<\/strong>
Presented by: Stephan Krause, PhD<\/strong>, Director, Product Quality, AstraZeneca<\/em><\/p>\n

[\/et_pb_text][et_pb_text admin_label=”Q&A” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

In each plenary session, the presentations will be followed by a live Q&A with the presenters who will answer questions from the audience.<\/span><\/p>\n

For more information on all this timely Conference has to offer, view the full agenda<\/strong><\/span><\/a>.<\/span><\/p>\n

Other sessions of interest include the closing regulatory panel discussion on the global perspective of lessons learned and how to further enable vaccine modernization in the future.<\/span><\/p>\n

The Conference will also offer multiple opportunities to connect and network with presenters and peers using the video chat function.<\/span><\/p>\n

Prepare for the future with a comprehensive look at how accelerated vaccine development and manufacture is changing the vaccines landscape.<\/span><\/strong><\/p>\n

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IABS Statistics Workshop
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Approaches for Improving Statistical Partnership in CMC Development, Manufacturing, and Regulation of Biologicals <\/span><\/strong><\/span><\/h3>\n<\/div>\n<\/div>\n

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November 2 \u2013 5, 2020 | Virtual<\/span><\/strong><\/span><\/h3>\n

[\/et_pb_text][et_pb_text _builder_version=”4.16″ text_font=”Adamina||||||||” text_text_color=”#000000″ text_font_size=”15px” header_2_font_size=”24px” header_3_font=”Adamina||||||||” header_3_text_align=”left” header_3_text_color=”#000000″ header_3_font_size=”20px” header_3_line_height=”2em” header_4_font=”Adamina|700|||||||” header_4_text_color=”#000000″ header_4_font_size=”17px” custom_margin=”||||false|false” border_color_all=”rgba(0,0,0,0)” inline_fonts=”Adamina” global_colors_info=”{}”]<\/p>\n

6th IABS Statistics Workshop Agenda<\/h4>\n

(PDF Download)<\/a>
<\/span><\/h4>\n

Session I: CMC statistics partnerships across the entire biologicals community
<\/strong>Chairpersons: Julia O\u2019NEILL, Direxa Consulting; Katherine GIACOLETTI, SynoloStats<\/em><\/p>\n

[\/et_pb_text][et_pb_button button_url=”https:\/\/www.iabs.org\/conferences\/upcoming-conferences\/24-upcoming-iabs-conferences\/174-3-4-november-2020-rockville-maryland” button_text=”Click Here” _builder_version=”4.16″ global_colors_info=”{}”][\/et_pb_button][et_pb_divider _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.16″ global_colors_info=”{}”][et_pb_cta title=”iPresent” button_url=”mailto:Julia@direxaconsulting.com” button_text=”Click Here” admin_label=”Call to Action iPresent” _builder_version=”4.16″ header_font=”Prata|700|||||||” header_font_size=”28px” background_color=”#0b1f8f” link_option_url=”mailto:Julia@direxaconsulting.com” box_shadow_style=”preset2″ global_colors_info=”{}”]<\/p>\n

Interested in scheduling a talk on Quality by Design, Data Mining for Process Understanding, Specification Setting, Design of Experiments, or other topics on the science of compliance?<\/p>\n

Accepting a limited number of speaking engagements each year. Virtual presentations a specialty.<\/p>\n

[\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”2_3,1_3″ _builder_version=”4.16″ global_colors_info=”{}”][et_pb_column type=”2_3″ _builder_version=”4.16″ global_colors_info=”{}”][et_pb_text _builder_version=”4.16″ header_2_font_size=”24px” header_3_font=”Adamina||||||||” header_3_text_align=”left” header_3_text_color=”#000000″ header_3_font_size=”18px” header_4_font_size=”14px” custom_margin=”||||false|false” global_colors_info=”{}”]<\/p>\n

2020 PDA\/FDA Joint Regulatory Conference<\/span><\/h2>\n

Sponsored by FDA and PDA<\/strong><\/h3>\n

<\/strong>Control strategy grounded in process modeling<\/strong><\/h3>\n

September 14 \u2013 16, 2020 | Virtual
<\/strong><\/h3>\n

[\/et_pb_text][et_pb_divider _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_divider][et_pb_text _builder_version=”4.16″ header_2_font_size=”24px” header_3_font=”Adamina||||||||” header_3_text_align=”left” header_3_text_color=”#000000″ header_3_font_size=”18px” header_4_font_size=”14px” custom_margin=”|||-10px|false|false” global_colors_info=”{}”]<\/p>\n

Statistically Speaking<\/span><\/strong><\/h2>\n

<\/strong><\/h3>\n

Demystifying Machine Learning<\/strong><\/h3>\n

A panel discussion with Dick DeVeaux and Russ Wolfinger<\/strong><\/h3>\n

Sponsored by JMP<\/strong><\/h3>\n

June 4th, 2020 | 1 – 2:30 pm (EST)<\/strong><\/h3>\n

[\/et_pb_text][et_pb_divider _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_divider][et_pb_text _builder_version=”4.16″ header_2_font_size=”24px” header_3_font=”Adamina||||||||” header_3_text_align=”left” header_3_text_color=”#000000″ header_3_font_size=”18px” header_4_font_size=”14px” custom_margin=”|||-10px|false|false” global_colors_info=”{}”]<\/p>\n

Accelerating Drug Commercialization<\/span><\/strong><\/h2>\n

<\/strong><\/h3>\n

A case for data driven experimentation<\/strong><\/h3>\n

Presented by JMP and Wiley CHEManager<\/strong><\/h3>\n

May 5th, 2020 | 2 – 3 pm (CEST)<\/strong><\/h3>\n

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EventsRecent Events8th Annual IABS Statistics Workshop \u2013 November 7 \u2013 10, 2022Advancing the Impact of CMC Statistics for a New Generation of Statisticians, Scientists, and Modelers November 7-10, 2022 A Virtual Meeting The application of statistics in Chemistry, Manufacturing & Control (CMC) to advance the development and commercialization of important medical products has tremendous impact. […]<\/p>\n","protected":false},"author":2,"featured_media":9841,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","_monsterinsights_skip_tracking":false,"footnotes":""},"class_list":["post-8721","page","type-page","status-publish","has-post-thumbnail","hentry"],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t